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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Amphotericin B lipid complex compared with amphotericin B in the treatment of cryptococcal meningitis in patients with AIDS.
- P K Sharkey, J R Graybill, E S Johnson, S G Hausrath, R B Pollard, A Kolokathis, D Mildvan, P Fan-Havard, R H Eng, T F Patterson, J C Pottage, M S Simberkoff, J Wolf, R D Meyer, R Gupta, L W Lee, and D S Gordon.
- Department of Medicine, UTHSCSA, San Antonio, Texas 78284, USA.
- Clin. Infect. Dis. 1996 Feb 1; 22 (2): 315-21.
AbstractThe study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B (AmB) lipid complex (ABLC) in the treatment of AIDS-associated cryptococcal meningitis. Of 55 patients randomly assigned to 6 weeks of therapy with ABLC (1.2-5.0 mg/[kg.d], with ascending doses for three sequential cohorts) or AmB (0.7-1.2 mg/[kg.d]), 46 received > or = 12 doses. Transfusion requirements, mean decreases in hemoglobin level, and mean increases in creatinine level were significantly greater with AmB than with ABLC. The total number of adverse events, infusion-related events, and occurrences of hypomagnesemia and hypokalemia associated with each form of therapy were similar. Among 21 recipients of ABLC at a dosage of 5 mg/kg (daily for 2 weeks and then thrice weekly for 4 weeks), symptoms and signs resolved for 18 (86%). Of those receiving > or = 12 doses of ABLC, cultures converted to negative for 8 (42%), were undeterminable for 3 (16%), and remained positive for 8 (42%) despite resolution of symptoms. Although preliminary, these data suggest ABLC has significant activity in patients with AIDS-associated cryptococcal meningitis. Because this formulation has less hematologic and renal toxicity than does AmB, further evaluation of ABLC is warranted.
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